Posted by Michael Wonder on 18 Jul 2016
Samsung Bioepis’ marketing authorization application for SB5 adalimumab biosimilar candidate accepted for review by the European Medicines Agency
18 July 2016 - If approved, SB5, a biosimilar candidate referencing Humira (adalimumab), will be Samsung Bioepis’ third anti-TNF-α biosimilar in Europe.
Samsung Bioepis Co., Ltd. today announced that the EMA has accepted for review the company’s marketing authorization Application for SB5, a biosimilar candidate referencing Humira (adalimumab).
SB5 is Samsung Bioepis’ third anti-TNF-α biosimilar candidate submitted for review to the EMA, following Benepali (etanercept) and Flixabi (infliximab), both of which have since received European Commission approval in January 2016 and May 2016, respectively. If approved, the marketing and distribution of SB5 in Europe will be handled by Biogen.
“If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We will continue to work hard to advance one of the industry's largest biosimilar pipelines, so that more patients can access affordable medicines without any compromise in the quality of treatment.”
